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Sponsor: Wake Forest University Health Sciences
Conditions: Breast Cancer Female, Early-stage Breast Cancer
Interventions: Lumpectomy, Intraoperative Radiation Therapy
Countries: United States
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Sex: FEMALE
Age: 55 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria: * Signed informed consent and HIPAA authorization * T1 tumor (less than or equal to 20mm in greatest diameter) * Unifocal * Histological Grade 1 or 2 * Node Negative * ER +ve * HER-2 -ve Exclusion Criteria: * Previous radiation therapy to the involved breast other than IORT within 6 months * High grade tumors (Histologic grade 3) * Her-2 Positive * Lymphovascular invasion * Metastatic disease * close proximity to or involvement of skin * Multifocal cancer
- Macon, Georgia, United States